MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; SPINAL NEEDLE

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received 2 used pencan 25gx3 1/2" (88mm)m.Fk-eu/ap/sa in open packaging.The provided samples were taken to a visual examination.At one used pencan sample, cannula is broken off approximately 45 mm away from the cannula hub.The structure of the break of the raw cannula shows that the cannula was bent before the break.The broken-off part with the cannula hub was not handed over by the customer.With regard to the used broken sample, the observed failure mode is consistent with problems during application and consider the complaint as not justified.We have informed our manufacturer accordingly a follow-up report will be provided after the dhr was finally checked.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): spinal needle broken; normal patient and usual spinal procedure puncture for a c-section.Seeing that no liquid flows back both the needle and sheath are removed to try a higher puncture.Upon removal of the needle only it is extracted noting that it is broken and checking through a tac that the rest of the needle has remained within the patient.

Manufacturer Narrative

(b)(4).Review of the manufacturing records: no abnormality was found.

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5835186
• MDR Text Key: 50805241
• Report Number: 9610825-2016-00532
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2016,07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 4502043-13
• Device Lot Number: 15M17H8B21
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2016
• Distributor Facility Aware Date: 07/07/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2016
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other